Abstract: The relative bioavailability of famotidine sustained-release (SR) tablets was studied in 16 healthy male volunteers. Famotidine plasma concentration was determined by HPLC method, and the plasma concentration-time data were processed with the method provided by USP XXIII. For single dose administration the peak plasma concentration occurring at 8.13±0.34 h was 69.52±3.00 ng/ml and the relative bioavailability was 112.4%±8.6%. For multiple dose administration the peak plasma concentration of SR tablet was 86.14±2.95 ng/ml and the degree of fluctuation (DF) was 140.6%±13.5% at steady state. Two one-sided tests were performed in bioequivalence assessment. The results showed that the sustained-release tablets were basically bioequivalent to the immediaterelease (IR) tablets on sale.

Key words: Famotidine, Bioavailability, HPLC